TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer

Inclusion Criteria:

- Female 18 years of age or older at the time the written informed consent is obtained

- Gynecologic Oncology Group (GOG) Performance Status of 0 or 1

- Life expectancy >= 3 months (per investigator opinion)

- Histologically or cytologically documented invasive epithelial ovarian cancer,
primary peritoneal cancer, or fallopian tube cancer (Subjects with pseudomyxoma ,
mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with
borderline ovarian cancer, ie, subjects with low malignant potential tumors, and with
clear cell or mucinous histology are excluded)

- Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer,
or fallopian tube cancer including at least a unilateral oophorectomy

- Radiologically evaluable disease per Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1 with modifications

- Subjects must have had one prior platinum-based chemotherapeutic regimen for
management of primary disease containing carboplatin, cisplatin, or another
organoplatinum compound. This initial treatment may have included intraperitoneal
therapy, high-dose therapy, consolidation therapy, bevacizumab or extended therapy
administered after surgical or non-surgical assessment.

- Adequate organ and hematological function

- Generally well controlled blood pressure with systolic blood pressure <= 140 mmHg and
diastolic blood pressure <= 90 mmHg prior to randomization. The use of
anti-hypertensive medications to control hypertension is permitted

- Radiographically documented disease progression either on or following the last dose
of prior chemotherapy regimen for epithelial ovarian cancer, primary peritoneal
cancer, or fallopian tube cancer

Exclusion Criteria:

- Subjects who have received more than 3 previous regimens of anti-cancer therapy for
epithelial ovarian, primary peritoneal or fallopian tube cancers

- Subjects who have received paclitaxel as consolidation therapy, maintenance, or
monotherapy are excluded

- Subjects with primary platinum-refractory disease

- Subjects with platinum-free interval (PFI) > 12 months from their last platinum based
therapy

- Radiotherapy <= 14 days prior to randomization. Subjects must have recovered from all
radiotherapy-related toxicities

- Previous abdominal or pelvic radiotherapy

- History of arterial or venous thromboembolism within 12 months prior to randomization

- History of clinically significant bleeding within 6 months prior to randomization

- History of central nervous system metastasis

- Has not yet completed a 21 day washout period prior to randomization for any previous
anti cancer systemic therapies (30 days for prior bevacizumab)

- Enrolled in or has not yet completed at least 30 days (prior to randomization) since
ending other investigational device or drug, or currently receiving other
investigational treatments

- Unresolved toxicities from prior systemic therapy that are Common Terminology
Criteria for Adverse Events (CTCAE) Version 3.0 >= Grade 2 in severity except
alopecia

- Known active or ongoing infection (except uncomplicated urinary tract infection
[UTI]) within 14 days prior to randomization

- Currently or previously treated with AMG 386, or other molecules that inhibit the
angiopoietins or Tie2 receptor

- Treatment within 30 days prior to randomization with strong immune modulators
including but not limited to systemic cyclosporine, tacrolimus, sirolimus,
mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, and
lenalidomide

- Clinically significant cardiovascular disease within 12 months prior to randomization

- Major surgery within 28 days prior to randomization or still recovering from prior
surgery

- Minor surgical procedures, except placement of tunneled central venous access device
within 3 days prior to randomization. Diagnostic laparoscopy is regarded as a minor
surgical procedure.